Why Do You Need A Doctor's Note To Get A Genetic Test?

from the makes-no-sense dept

There have been a bunch of personal genetic testing services popping up over the past couple of years. One of the most well known is 23andMe, who got a PR lift for being founded by Sergey Brin's wife -- and also getting an investment from Google. Typically, the program lets people send in a cheek swab and receive back personal genetic info. These services are still in their early stages, but the few folks I know who have used 23andMe have found it to be an interesting learning process. However, now it's coming out that 23andMe and other personal genetic testing services may actually be breaking California law. California has sent a bunch of these firms cease-and-desist letters demanding they close up shop until certain conditions are met.

Apparently any labs doing the tests need to get both state and federal certification and can only do tests based on a physician's recommendation. The state claims it sent the letters after receiving "multiple consumer complaints about the accuracy and costs of genetic testing advertised on the Internet." This seems quite questionable for a variety of reasons. First, if people have "complaints" about the costs... then the proper response is to simply not buy the test. I have complaints about the price of Ferraris, but I'm not going to complain to the state of California -- and I doubt that the state would send cease and desist letters to Ferrari dealers.

Secondly, it seems quite ridiculous to say that these sorts of tests can only be taken with permission from a physician. There seems no reason not to let those who are willing to pay the associated fees to get a personal genetic test without involving a physician at all. As we move more and more towards more personalized medicine, this problem is only going to come up more and more. Not all medical tests and treatments need to be done under a doctor's care -- and requiring it in all cases seems more like a way to protect physicians' fees rather than citizens' health.

Ultimate ID Theft

There is one reason I can think of to control this: how do you know the DNA is from the person they say it is? Getting someone else's DNA information seems like the ultimate form of identity theft, and, although it would be difficult to use such information today, that information will no doubt become useful in the near future.

Great article. Next we're gonna say women need a doctor's permission before taking a pregnancy test! I mean, what if they read it wrong and think they're pregnant? The horror! Let's have a little more faith in the consumer, people...

Ethical Regulation

How do we know the "genetic testing" company did not make up data? How do we know they will not sell the genetic information to e.g. the person's insurance company, who will then hike rates because they are at elevated risk for some disease?

I'll add that the science of determining a person's risk factor for most diseases, or determining their ethnic background is still poorly developed. While DNA tests are quite accurate for matching crime scenes or paternity tests, the science of guessing a person's ethnic background or their risk for developing cancer is still very poorly developed. News headlines made a big deal out of the "BRCA-1" and "BRCA-2" genes that predict breast cancer, but the data came from a small group of Orthodox Jewish women. It is well known that the same disease can have completely different genetic origins in differing populations; there are many genes that cause hemophilia, for example.

Furthermore, these "genetic testing" companies are scamming rich people by telling them they are descended from Genghis Khan, that they are part (insert ethnic group), etc. when the science is dubious in the extreme. The data on ethnic distinctions in DNA is still very sparse, and there is a lot of overlap anyway.

Law

"and can only do tests based on a physician's recommendation"

Dose this mean that all court ordered genetic testing is illegal in California, since those court orders come without a physician's recommendation? Is there a loophole that the California courts are using to circumvent this?

All in all it, dose seem stupid that I can't choose to get a genetic test with out the approval of a doctor; it's a test, not treatment.

Traditionally...

I used to work in a hospital laboratory, back before HIV became the issue it is today - back when it was "safe" to work around blood and bodily fluids...

When I transitioned through the Serology department, the first thing they taught me was "when a patient calls and asks about the results of the test(s) - you tell them to call their doctor - you never, ever, ever give results directly to a patient".

I asked why and the answer (which now seems obvious) is that you don't know the context in which the test was performed - you don't know if the patient wants a positive or negative result and you're not trained to tell a patient that (s)he is positive for a life-threatening disease, or that the couple who have been trying for 30 months to conceive don't want to hear that their pregnancy test result is negative. You can't always assume that what you think is good news is what the patient wants to hear.

If you take a cheek swab from your infant and send it on for DNA profiling, do you want a form letter printed from a computer that says "Your sample show a high probability of a crippling genetic condition and you will be lucky to live long enough for a second birthday"? Or would you rather have a doctor explain it to you and be there to answer the questions that you are no doubt going to have?

I don't necessarily agree that it needs to be a law that doctors have to be involved, but there are good reasons for wanting a doctor to be between you and the lab.

Re: Ethical Regulation

I don't think any of that is solved by having a doctor's note required, and very little of it (possibly none) would be solved by requiring state OR federal certification. What this IS, though, is a way to pad the treasury with certification fees and minimize the market for such services.

"The Genetic Information Nondiscrimination Act was signed into law Wednesday [May 21, 2008] by President Bush, after passing overwhelmingly in the House and Senate.

Described as the first major civil rights act of the 21st century, the law protects people from losing their jobs or their health insurance if genetic tests show they are at risk for cancer, heart disease or other illnesses."
-Chicago Sun-Times, May 22, 2008, by Monifa Thomas

We also know that the company didn't make up the data because it is sent directly to a lab at a company called Illumina in California that uses high-tech equipment to study the DNA sample and send the results to 23andme. Nice try though.

Re:

Oh Dorpus. Do your research:

"The Genetic Information Nondiscrimination Act was signed into law Wednesday [May 21, 2008] by President Bush, after passing overwhelmingly in the House and Senate....

We also know that the company didn't make up the data because it is sent directly to a lab at a company called Illumina in California that uses high-tech equipment to study the DNA sample and send the results to 23andme. Nice try though.

Just because a law is passed does not mean it is enforced. Which agency enforces this law? How do we know Illumina is not a participant in the scam? Should we have believed Enron when they claimed to manage California's electricity supply better than the government did?

Interpretation

Doctors interpret your Xrays, MRIs, Lab results, EKGs, why is it so inplausible to think that we should not interpret your genetic results also? Do you all really think that what what comes out of the machine is a simple and straightforward "Yes & No" answer?

Re: Re: Ethical Regulation

I don't think any of that is solved by having a doctor's note required, and very little of it (possibly none) would be solved by requiring state OR federal certification. What this IS, though, is a way to pad the treasury with certification fees and minimize the market for such services.

So if a genetic testing company told you that you have 2 years left to live because you have the genes for some deadly disease, would you prefer to pad the treasuries of companies that claim to cure the disease before it happens?

Genetic test results are often not straight forward and do require some discussion with the patient about the interpretation of the test. As a genetic counselor I encounter daily how laypersons AND physicians misinterpret genetic test results. I do have concerns about genomic testing and how patients may interpret their results.

Re: Interpretation

Doctors receive training in medical school and residency regarding interpretation of various testing; however, they do not receive training on interpretation of genetic test results - unless they do a fellowship in Genetics. I do hope that, as with any other ambiguous test result, that physicians consult with a specialist before interpretation of these complex results.

From a law enforcement perspective...

There needs to be medical (or other approved) personnel involved in order to complete a 'chain of evidence'. For instance, what if your daughter was raped and you had dna evidence that you wanted examined. Instead of taking it upon yourself and 'damaging' the evidence, you would need a medical professional (with set procedures of handling the evidence) or an officer (also with set procedures of handling the evidence) to witness the collection, packaging and delivery to the lab. The same issue would happen with paternity tests, to be sure that the 'evidence' isn't tampered with on the way to the lab.

Re: Re:

I don't think most people (myself included) would be able to properly interpret results from a genetic test...

I don't see how that's the lab's concern, or the government's. Perhaps the lab can ad value by providing (for additional cost?) a detailed explanation of the results (assuming this isn't already done). Or people should just consult a physician after the fact when they don't understand the results. What shouldn't happen is insisting the government coddle us because we might misinterpret something and can't be trusted to actively take care of ourselves.

After all, most women upon recieving a positive result on a pregnancy test subsequently consult a doctor for advice and council on what to do next. But they can manage the "recieving test results" fine on their own.

Re: Re: Re: Ethical Regulation

Re: Re:

Which agency enforces this law?

Probably the Executive, through law enforcement agencies commonly known as "police." Though if there's a dispute, I guess that could go to the "courts."

Or do you expect us to stand up a new government agency everytime we determine a new crime that could be committed? Hell, we already have mechanisms in place to punish other kinds of discrimination on other protected classes, that's not good enough for you?

Re: Re: Re: Interpretation

Right. So why should we mandate that someone consult a physician on the results of a test? That's not even the question at hand -- why should we require by governmental mandate that you get permission from a doctor before having the test done? I'm sorry, I don't think I need a doctor to hold my hand through that decision.

Re: Re: Re:

Probably the Executive, through law enforcement agencies commonly known as "police." Though if there's a dispute, I guess that could go to the "courts."

Or do you expect us to stand up a new government agency everytime we determine a new crime that could be committed? Hell, we already have mechanisms in place to punish other kinds of discrimination on other protected classes, that's not good enough for you?

Law enforcement agencies have specific mandates on which laws they enforce. There are plenty of crimes the FBI does not investigate, because they are not mandated to enforce them. Unless the genetic testing law was assigned to a specific agency, the law is useless.

Re: Why?

Re: From a law enforcement perspective...

Right. These results wouldn't be admissable in a court of law. But that's not thje question. The question is why we shouldn't be allowed to do it without governmental/physician hand-holding. I'm not trying to get a man sent to prison, I'm just curious what my personal results would be.

Re: Re: Re: Re:

You're right. And since you don't know who it was assigned to, it must not have been assigned. Oh well, chalk it up to more unnecessary, unenforcable legislation. It's not like someone who suspects wrong doing would ever take the case to court, anyways.

Re: Re: From a law enforcement perspective...

Right. These results wouldn't be admissable in a court of law. But that's not thje question. The question is why we shouldn't be allowed to do it without governmental/physician hand-holding. I'm not trying to get a man sent to prison, I'm just curious what my personal results would be.

So would you want to pay thousands of dollars for "test results" that may have been fabricated by a random number generator, or got mixed up with somebody else in the lab? If you don't want the government to "hold your hand", then the private sector will happily take money out of your hand instead.

Re: Re: Re: From a law enforcement perspective...

The obvious answer is, "no." I don't want to be scammed. But I think there are plenty of other ways to combat scamming that don't require the government to limit what I can and cannot do. If they're defrauding people, get them on fraud. If they're results are inaccurate, a competetor will out-sell them. None of this requires the government to step in and tell me I might get hurt, or I might not understand the results, and so I'm not allowed to request the service. The less the government is involved in my life, the happier I am.

Re: Re: Re: From a law enforcement perspective...

No, but that is my decision to make, not yours and not the governments.

Consider cars for example, some are great and some are shit boxes. Thats why I look at consumer reports before I buy a car.

People feel that we need the government to tell us whats good and whats not, whats safe and whats not. Let the people make the choice. If there is a significant risk in the product, than the market can provide ample solutions without government involvement (i.e. Consumer Reports, Zagats, Underwriters Laboratories, etc)

Re: Interpretation

I think you make a very valid point. The majority of Americans probably do not understand a lot of the science behind genetics, much less risk factors for diseases in different ethnic groups, etc. I've personally never seen an example of what any of these tests look like once sent back to the consumer, but I doubt they are easy to understand.

I think that it is critical one orders a genetic test under the guidance of a doctor at the least, perhaps a genetic counselor if one can be afforded. Risk factors and diseases are not black and white: there is a great deal of grey area, and even many "risk factors" are still poorly understood and are still in the research phases.

However, if someone wants to get a genetic test solo and does not decide to see a doctor about the results and misinterprets them...that's their own problem. The law shouldn't have to force people to make an intelligent choice.

Why is this any different than drug testing?

I am bothered by a state saying that genetic testing requires permission from a doctor, yet drug testing has many of the same risks in terms of privacy, interpretation, and accuracy. Yet there seems to be no need for a doctor's permission for an employer to demand drug testing and results - sent to them - not the person tested.

There does not seem to be a uniform concern for the consumer/patient even though the same labs can process both types of tests.

Perhaps the state of California should also require a doctor's permission for drug testing as well.

Re: Re: Re: Re: From a law enforcement perspective...

But your argument is somewhat flawed. The government sets minimum safety standards for all cars sold in the US. Usually what differentiates cars would be luxuries and performance beyond the minimum. But the government does not allow people to buy cars that crumple like aluminum cans.

This is similar to that. The government is not limiting who you can take the test from. But they are providing a safeguard against a number of things.

This law is simply protecting the average citizen. Much like how perscription drugs require diagnosis by a skilled physician and a further perscription to prevent abuse. If this sort of cautiousness is unwarranted, the law will be repealed, or ignored. But its better to have some safeguards, if flawed, then none at all.

Whether or not the consumer understands is irrelevant

Whether or not the consumer understands their genetic information is irrelevant. You don't see people hanging around Borders and, whenever anyone goes near a copy of Wolfram's _A New Kind of Science_, asking, "Do you know about cellular automata? Are you qualified to read this?" Anybody can buy a book they cannot understand, about any topic.

If the book happens to be filled with DNA sequences and information about your single nucleotide polymorphisms, that makes no difference.

Re: Re: Re: Re: Re: From a law enforcement perspective...

I understand there is a flaw in the argument, although since we (unfortunately) do not live in a free market society, a perfect example is quite hard to come by.

I fail to understand what the government is safeguarding against in this case. Privacy issues, etc. have been cited in these comments. Do organizations with strict government oversight not have privacy issues? I think not. The industry could be regulated to death and still have all the problems described here.

As to your example, I would argue that the governments involvement in the pharmaceutical industry has severely limited our ability to innovate. As a case in point, an uncle of mine just died from a disease for which there is no current (recognized by FDA) treatment. There are, however, experimental treatments which have not yet received FDA approval. He was going to die very shortly anyway, and yet you will have me believe that the FDA's barring him from these potentially life saving treatments somehow was protecting him?

I will reiterate: Let people decide for themselves. It is not the governments place to protect us from ourselves, nor should it be.

Re:

you're exactly right--you also have to have a doctor's permission and CAN'T RECEIVE YOUR OWN RESULTS DIRECTLY if you take some of the fertility tests like Repromedix's Plan Ahead test. makes absolutely no sense--they send results to the doctor and you have to get them forwarded on.

empower us to receive, manage and own our own health information. it's that simple.

Re: Re: Re: Re: Re: From a law enforcement perspective...

If it was just certification, I might allow you to bring in automobile safety standards. That doesn't limit a consumer's ability to seek service, just who can offer service. But requiring a physician's approval would be like requiring a police officer's blessing to buy a car.

Perscription drugs are another beat entirely. In that case we're talking treatment, and unwarrented or erroneous treatment can be hazardous: most people DON'T know enough to treat themselves. DNA screening is just a test, though, and as noted most people are quite capabile of recieving (if not necessarily interpretting or acting upon) test results. I shouldn't need a doctor to tell me it's OK to get a test done.

Re: Interpretation

For some reason everyone seems outraged that the government wants to try and protect them.

Aside from all the misdirected comments about the norm of getting orders for largely medical procedures.

Has anyone ever considered that this is a good thing? That by mandating government & medical oversight we are stopping companies from mandating genetic screening as part of the hiring process, or insurance companies from requiring it as part of the application process?

Can you imagine if genetic screening entered the free market? This is totally unlike drug testing or pregancy testing. Both of which are temporary personal choice conditions. Did some drugs in high school? Thats ok, just stay clean for a while and they won't show up on your record.

With genetic testing, your make-up never changes, one test and someone could potentially see your risk for all types of cancers or defects. Would you or even your kids or grandkids want to be discriminated against based on your genetic makeup? Because thats what you're asking for if you side with this entering the free market.

If you regulate it then companies can't touch it, and if they try then there are a lot of necks to wring if something bad does happen to the public.

To the comment on FDA approval.

I used to work for a pharmaceutical company. Trust me, "cures" and "experimental procedures" are thought up by marketing departments. R&D is literally mixing stuff together and testing it on rats to see what it does. If your uncle was dying of a disease and they didn't want to let him try an unapproved research medication it was in his best interest. Subjects dying of disease are a research protected population since they are so willing to try anything.

This is about who owns my body - and therefore any data derived from my body. The lab is just translating something that's too small for me to see with typical home equipment into a printout. The DNA is mine; the printed form of the DNA map is mine also. Period.

Unfortuanately, current body of law does not reflect the idea that you own your body. For example, if a patentable drug is directly derived from something inside your biochemistry, you have no claim to it whatsoever. Only the company that "developed" it has claim.

Amazing but true.

Back to the point: My DNA, whether in molecular form or printout form. Mine. Period. Paying someone to translate the data form one format to another should absolutely not require the "permission" from an MD any more than paying a company to translate the data on an old floppy to a modern USB key should require the "permission" of your nearest certified IT expert. My data.

If we don't begin to fight these laws NOW, the ownership of our own bodies will continue to be taken from us.

Re: Re: Interpretation

For some reason everyone seems outraged that the government wants to try and protect them.

Perhaps that's because a lot of people are sick and tired of the gov't "protecting" them from things they don't need to be protected from. Especially, when nearly every "protection" is really more about ensuring a monopoly for some special interest group.

Has anyone ever considered that this is a good thing? That by mandating government & medical oversight we are stopping companies from mandating genetic screening as part of the hiring process, or insurance companies from requiring it as part of the application process?

Wow. That's got absolutely nothing to do with this story. Both of the scenarios you describe are already covered by existing laws that have NOTHING to do with getting a personal genetic screening.

Can you imagine if genetic screening entered the free market?

Yes. I think it would be fantastic. Just read "The End of Medicine" to get a sense why.

With genetic testing, your make-up never changes, one test and someone could potentially see your risk for all types of cancers or defects. Would you or even your kids or grandkids want to be discriminated against based on your genetic makeup? Because thats what you're asking for if you side with this entering the free market.

You are being TOTALLY misleading. That can be taken care of (and is) by anti-discriminatory hiring laws. That has nothing to do with an individual getting a test for their own interest.

I used to work for a pharmaceutical company.

Ah, well that explains everything.

Forget what I said about "The End of Medicine." That'll make you go ballistic.

Re:

Re: Re: Ethical Regulation

I think someone is reaching.

dorpus has claimed in the past to work in the health care industry; he isn't exactly unbiased. He often takes positions opposed to people having control over their own health care or even being able to freely select their own doctors.

What is there to know?

This whole string has been a stretch. I would like to ask a question.

If you get a whole genome from Mumbai or San Fran......"What is there to know?" What possible information could you glean from just a mere genome...which right now isn't even a true genome. Nor does it represent the entire book of you....in fact it isn't even a chapter in the book....so to all the "self-knowledgers" out there.....try and trust wikipedia or google on this....most of that information is faulty....and you likely will not be able to read it...if you can....it will be out of date in 6 months to 1 year....assuming it is currently correct information...

So I ask.....Now you have your "pseudo" genome.....
"What is there to know?"